FDA UDI
In Commercial Distribution
🇺🇸 United States
Respiratory Gating for Scanners (RGSC)
DI: 00856100006196
·
Model: 2.0
·
Varian Medical Systems Imaging Laboratory GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Respiratory Gating for Scanners (RGSC)
- Primary DI
- 00856100006196
- Version / Model
- 2.0
- Company Name
- Varian Medical Systems Imaging Laboratory GmbH
- Labeler DUNS
- 482243784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-21
- Public Version
- 1
- Public Version Date
- 2022-04-29
- Public Version Status
- New
- Public Device Record Key
- 0a0287a2-0bd3-4009-820a-01129a1a1918
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAK | System, x-ray, tomography, computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45065 | Real-time position management respiratory gating system, optical | An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856100006196 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213927 | 000 |